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A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

Phase 1/Phase 2
20 Years
70 Years
Open (Enrolling)
Peripheral T Cell Lymphoma Unspecified, Anaplastic Large Cell Lymphoma, ALK-negative, Angioimmunoblastic T Cell Lymphoma, Cutaneous T Cell Lymphoma

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Trial Information

A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas

Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 +
CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 +
CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2
+ D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone
100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks Treatment
will be continued until planned 6 cycles or disease progression

Inclusion Criteria:

1. Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative
anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma
(AITL), Cutaneous T-cell lymphoma

2. Adequate organ function as defined by the following criteria:

A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT))
and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5
x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to
5 x ULN if liver function abnormalities are due to underlying malignancy B.Total
serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets
≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated)
F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN

3. At least one measurable lesion

4. ECOG PS 0-2

5. Informed consent

6. Age 20 to 70 years old

Exclusion Criteria:

1. Prior radiation therapy or surgery within 4 weeks prior to study entry

2. History of central nervous system (CNS) metastases

3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2.

4. Pregnancy or breastfeeding.

5. Hepatitis B virus surface antigen positive

6. Extranodal NK/T cell lymphoma

7. Mycosis fungoides

8. ALK-positive Anaplastic large cell lymphoma

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determination of the maximum tolerable dose and evaluation of response rate

Outcome Time Frame:

Phase I for maximal tolerable dose and phase II for efficacy

Safety Issue:


Principal Investigator

Won Seog Kim, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Peripheral T Cell Lymphoma Unspecified
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • Angioimmunoblastic T Cell Lymphoma
  • Cutaneous T Cell Lymphoma
  • RAD001
  • chemotherpy
  • T cell lymphoma
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic